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About CSI

We are devoted to developing innovative solutions for treating peripheral and coronary artery disease, to help physicians conquer calcium, one of the largest challenges when treating PAD and CAD and help patients get back to what matters.

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Clinical Evidence

INDICATIONS & IMPORTANT SAFETY INFORMATION

DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS)
Indication: To facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions; A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.
See the Instructions for Use before performing DIAMONDBACK 360® coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.DIAMONDBACK 360® Peripheral Orbital Atherectomy SystemIndications: For use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Our commitment to clinical evidence

Physicians and payers are increasingly requesting evidence to help them make decisions regarding optimal treatment of patients.

We are focused on conducting outcomes research and collecting orbital atherectomy clinical evidence to offer details concerning outcomes in treating patients with peripheral artery disease and coronary artery disease.

We believe that the clinical benefits of our orbital atherectomy technology will help drive physician utilization and improve access for indicated patients to this treatment option.

Information

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CSI® distributes products listed on this website within the United States. For more information about product availability globally, please click to find out more about our international distribution partners listed below by geography.

Smart Solutions that advance treatment for complex patients

At CSI, weare a culture of innovation.
We observe carefully, listen closely and collaborate extensively,
seeking opportunities to help interventionalists do their jobs more easily and more effectively –
all with the goal of improving patient care.